{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Mercedita", "state": "PR", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "72900", "recalling_firm": "Zimmer Manufacturing B.V.", "address_1": "Turpeaux Industrial Park Rd 1 km 123.4", "address_2": "", "postal_code": "00715", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide Distribution", "recall_number": "Z-1115-2016", "product_description": "Product 17 consists of all product under product code: LPH and same usage: Item no:\t 625004515\tBONE SCREW 4.5X15 SELF-TA 625004520\tBONE SCREW 4.5X20 SELF-TA 625004525\tBONE SCREW 4.5X25 SELF-TA 625004530\tBONE SCREW 4.5X30 SELF-TA 625004535\tBONE SCREW 4.5X35 SELF-TA 625004540\tBONE SCREW 4.5X40 SELF-TA 625004550\tBONE SCREW 4.5X50 SELF-TA 625006515\tBONE SCREW 6.5X15 SELF-TA 625006520\tBONE SCREW 6.5X20 SELF-TA 625006525\tBONE SCREW 6.5X25 SELF-TA 625006530\tBONE SCREW 6.5X30 SELF-TA 625006535\tBONE SCREW 6.5X35 SELF-TA 625006540\tBONE SCREW 6.5X40 SELF-TA 625006550\tBONE SCREW 6.5X50 SELF-TA 625006560\tBONE SCREW 6.5X60 SELF-TA 625006570\tBONE SCREW 6.5X70 SELF-TA Product Usage: For use in total or hemi hip arthroplasty", "product_quantity": "87341", "reason_for_recall": "As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. 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